Posting of Accounts and Notice of AGM

Posted on by Simon Sacerdoti

Destiny Pharma plc
(“Destiny Pharma” or “the Company”)

Posting of Annual Report and Accounts, and Notice of AGM

Brighton, United Kingdom – 23 April 2018 – Destiny Pharma (AIM: DEST), a clinical stage biotechnology company focused on the development of novel anti-microbial drugs, which address the global problem of anti-microbial resistance (AMR), announces that the annual report and accounts of the Company for the year ended 31 December 2017 (“Annual Report”), and the notice of the Company’s Annual General Meeting (“AGM”) are now available on the Company’s website at www.destinypharma.com

The Annual Report will be posted to shareholders today.

The AGM is to be held at 10.00am on 31 May 2018 at the offices of FTI Consulting LLP at 200 Aldersgate, London EC1A 4HD.

Clinical update

Posted on by Simon Sacerdoti

THE INFORMATION CONTAINED WITHIN THIS ANNOUNCEMENT IS DEEMED BY THE COMPANY TO CONSTITUTE INSIDE INFORMATION AS STIPULATED UNDER THE EU MARKET ABUSE REGULATION (596/2014). UPON THE PUBLICATION OF THE ANNOUNCEMENT VIA A REGULATORY INFORMATION SERVICE, THIS INFORMATION IS CONSIDERED TO BE IN THE PUBLIC DOMAIN.

Destiny Pharma plc
(“Destiny Pharma” or “the company”)

Destiny Pharma announces update on clinical programme for lead drug candidate XF-73

Started recruiting subjects in latest Phase 1 dermal study under US IND

FDA discussions have clarified overall clinical trial plans for XF-73

Phase 2b study on track to announce results in H2 2019

Brighton, United Kingdom – 12 April 2018 – Destiny Pharma (AIM: DEST), a clinical stage biotechnology company focused on the development of novel anti-microbial drugs, which address the global problem of anti-microbial resistance (AMR), today announces an update on the scope and timing of the XF-73 (exeporfinium chloride) Phase 1 and Phase 2b clinical trial programmes following discussions with the US Food and Drug Administration (FDA). This process is in line with the Company’s strategy set out at the time of the placing and admission to AIM and the current status is summarised below:

  • As previously announced, in February 2018, Destiny Pharma opened an Investigational New Drug (IND) application and, in March 2018, was awarded Fast Track designation for the XF-73
  • Destiny Pharma announces today that a Phase 1 dermal safety study, looking at potential skin irritation of XF-73 solution in up to 30 subjects, has started in a specialist US based unit
  • The FDA has clarified that only one additional Phase 1 dermal safety study,looking at skin irritation of XF-73 nasal gel in up to 30 subjects ,has to be completed before the planned Phase 2b trial can start
  • Destiny Pharma is pleased to note that the FDA confirmed that the additional, larger, Phase 1 dermal safety study, looking at the potential for skin sensitisation of XF-73 nasal gel in 200 subjects, does not need to be completed before the Phase 2b study and is only required in advance of the start of Phase 3 trials. Destiny Pharma plans to complete this larger skin sensitisation study in parallel with the Phase 2b in 2019
  • With these clarifications Destiny Pharma is now finalising plans to start the Phase 2b trial. This trial will assess the efficacy of XF-73 against placebo in the nasal decolonisation of Staphylococcus aureus in approximately 150 patients prior to their undergoing hospital surgical procedures. The Company is on track to announce Phase 2b results in the second half of 2019, with the aim of delivering a Phase 3 ready package by the end of 2019

Neil Clark, Chief Executive Officer of Destiny Pharma, commented:

“We are very pleased to get this confirmation from the FDA on the clinical pathway for our lead asset, XF-73. As we set out at the time of our admission to AIM, once the IND and Fast Track designation were confirmed we were expecting to be able to parallel track some of the standard Phase 1 studies and our Phase 2b study based on the existing safety profile of XF-73, and the FDA has now confirmed that this approach is appropriate. Over 160 subjects to date have been dosed with this potentially breakthrough antibacterial drug as a nasal formulation with no significant issues. The Company is well funded and the team at Destiny Pharma remains fully focused on delivering the agreed clinical plan.”

XF-73, Destiny Pharma’s lead asset, is a first-in-class drug candidate, initially being developed for the prevention of post-surgical staphylococcal infections, such as methicillin-resistant Staphylococcus aureus (MRSA), which cause significant complications and increased healthcare burden in the hospital setting.

 

For further information, please contact:

Destiny Pharma plc
Neil Clark, CEO
Simon Sacerdoti, CFO
pressoffice@destinypharma.com
+44 (0)1273 704 440

FTI Consulting
Simon Conway / Victoria Foster Mitchell
destinypharma@fticonsulting.com
+44 (0) 20 3727 1000

Cantor Fitzgerald Europe (Nominated Adviser and Joint Broker)
Philip Davies / Will Goode, Corporate Finance
Andrew Keith, Healthcare Equity Sales
+44 (0)20 7894 7000

 finnCap Ltd (Joint Broker)
Geoff Nash /Kate Bannatyne, Corporate Finance
Alice Lane, Corporate Broking
+44 (0)20 7220 0500

 

About Destiny Pharma

Destiny Pharma is an established, clinical stage, innovative biotechnology company focused on the development of novel medicines that represent a new approach to the treatment of infectious disease. These potential new medicines are being developed to address the need for new drugs for the prevention and treatment of life-threatening infections caused by antibiotic-resistant bacteria, often referred to as “superbugs”. Tackling anti-microbial resistance has become a global imperative recognised by the WHO and the United Nations, as well as the G7 and the G20 countries. For further information, please visit https://www.destinypharma.com

Forward looking statements

Certain information contained in this announcement, including any information as to the Group’s strategy, plans or future financial or operating performance, constitutes “forward-looking statements”. These forward looking statements may be identified by the use of forward-looking terminology, including the terms “believes”, “estimates”, “anticipates”, “projects”, “expects”, “intends”, “aims”, “plans”, “predicts”, “may”, “will”, “seeks” “could” “targets” “assumes” “positioned” or “should” or, in each case, their negative or other variations or comparable terminology, or by discussions of strategy, plans, objectives, goals, future events or intentions. These forward-looking statements include all matters that are not historical facts. They appear in a number of places throughout this announcement and include statements regarding the intentions, beliefs or current expectations of the Directors concerning, among other things, the Group’s results of operations, financial condition, prospects, growth, strategies and the industries in which the Group operates. The directors of the company believe that the expectations reflected in these statements are reasonable, but may be affected by a number of variables which could cause actual results or trends to differ materially. Each forward-looking statement speaks only as of the date of the particular statement. By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future or are beyond the Group’s control. Forward looking statements are not guarantees of future performance. Even if the Group’s actual results of operations, financial condition and the development of the industries in which the Group operates are consistent with the forward-looking statements contained in this document, those results or developments may not be indicative of results or developments in subsequent periods.

 

 

Audited results for the year ended 31 December 2017

Posted on by Simon Sacerdoti

Destiny Pharma plc
(“Destiny Pharma” or “the Company”)

Audited results for the year ended 31 December 2017

Well funded and on track to deliver Phase 2b headline data in H2 2019 for lead
asset, XF-73,a novel anti-microbial

 Brighton, United Kingdom – 12 April 2018 – Destiny Pharma (AIM: DEST), a clinical stage biotechnology company focused on the development of novel anti-microbial drugs, which address the global problem of anti-microbial resistance (AMR), announces its audited financial results for the year ended 31 December 2017.

Financial highlights

  • Successfully completed placing and admission to AIM, raising £15.3 million
  • Additional £3.0 million invested by China Medical Systems Holdings Ltd
  • Strong cash position with cash and term deposits at 31 December 2017 of £16.7 million (2016: £1.5 million)

Operational highlights

  • China and Asia regional development and collaboration agreement signed with China Medical System Holdings Ltd (CMS)
  • Patent portfolio strengthened with the grant of the South Korean XF-biofilm patent
  • Board and executive management team strengthened with the appointment of Neil Clark as CEO, Dr Bill Love, founder of the Company, as Chief Scientific Officer and Dr Huaizheng Peng, General Manager of International Operations at CMS, as Non-executive Director

Post-period highlights

  • US Investigational New Drug (IND) application opened for XF-73
  • US Food and Drug Administration (FDA) Fast Track designation granted for XF-73
  • First subject enrolled in a Phase 1 dermal safety study for XF-73
  • Clarification, through dialogue with the FDA, of the Phase 1 and Phase 2b clinical trials programme – further details of which can be found in a separate announcement released this morning
  • Patent portfolio expanded with the grant of Canadian XF-biofilm patent

Neil Clark, Chief Executive Officer of Destiny Pharma, commented:

“In 2017, we built on the existing strong foundations of Destiny Pharma, successfully completing the placing admission to AIM which raised significant additional capital to progress our pipeline through the planned clinical studies, and executing a key strategic partnership in Asia with China Medical Systems to help realise our commercial aspirations.

“In 2018, progress has continued to be been strong for our lead candidate, XF-73, with the opening of the IND and award of Fast Track designation. Subsequent discussions with the FDA have clarified the clinical pathway for XF-73. We remain on track to deliver Phase 2b results in H2 2019 as part of a Phase 3 ready package. Importantly, our market analysis continues to support the clinical need and commercial opportunity for XF-73 in the prevention of post-surgery hospital infections, such as MRSA, which is estimated to be over a $1 billion market opportunity.

“The Company is well funded following the placing at the time of admission to AIM and, whilst our main focus is on our lead asset, we are also looking to progress our earlier pipeline and develop our collaboration with China Medical Systems. There is continuing international support for the development of novel anti-infective drugs that address the issue of anti-microbial resistance and Destiny Pharma’s unique platform is very well-positioned to meet this global need.”
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The full text of the announcement may be found here.

Appointment of Joint Broker

Posted on by Kirsty Richardson

Destiny Pharma (AIM: DEST), announces the appointment of finnCap Ltd as joint broker to the Company with immediate effect.  Cantor Fitzgerald Europe remains nominated adviser and joint broker to the Company.

Destiny Pharma announces FDA Fast Track Designation for lead clinical candidate, exeporfinium chloride (XF-73)

Posted on by Simon Sacerdoti

THE INFORMATION CONTAINED WITHIN THIS ANNOUNCEMENT IS DEEMED BY THE COMPANY TO CONSTITUTE INSIDE INFORMATION AS STIPULATED UNDER THE EU MARKET ABUSE REGULATION (596/2014). UPON THE PUBLICATION OF THE ANNOUNCEMENT VIA A REGULATORY INFORMATION SERVICE, THIS INFORMATION IS CONSIDERED TO BE IN THE PUBLIC DOMAIN. 

Destiny Pharma plc
(“Destiny Pharma” or “the Company”)

Destiny Pharma announces FDA Fast Track Designation for lead clinical candidate, exeporfinium chloride (XF-73)

Brighton, United Kingdom – 15 March 2018 – Destiny Pharma (AIM: DEST), a clinical stage biotechnology company focused on the development of novel anti-microbial drugs, which address the global problem of anti-microbial resistance (AMR), today announces that its lead clinical candidate exeporfinium chloride (XF-73) has been granted Fast Track designation by the US Food and Drug Administration (FDA) for the prevention of post-surgical staphylococcal infections such as Methicillin Resistant Staphylococcus aureus (MRSA). This follows the FDA’s acceptance in February 2018 of an Investigational New Drug (IND) Application by the Company for the potentially ground-breaking drug.

Fast Track Designation is one of a package of measures and incentives available under the FDA’s Qualifying Infectious Disease Product (QIDP) programme, set up to encourage development of novel ant-infective drugs. XF-73 was awarded QIDP status in October 2015.  Fast Track designation is intended to expedite the potential availability of a drug to patients which, in the view of FDA, has promise in treating a serious or life-threatening condition and to fulfil an unmet medical need.

Neil Clark, Chief Executive Officer of Destiny Pharma, commented:

“We are pleased to have received Fast Track designation from the FDA for XF-73. This represents a further recognition of the potential for the drug and the need for an effective prevention for post-surgical staphylococcal infections, such as MRSA, that can result in significant complications for patients and significantly increased costs for hospitals. On our analysis of published data, there are approximately 40 million surgeries per annum, in the USA alone, where the patient is at risk of a post-surgical infection, We look forward to continuing our clinical development of XF-73 which remains on track and we expect Phase II data in 2019.”

XF-73 has been developed from Destiny Pharma’s novel, antimicrobial “XF” drug platform. Unlike traditional antibiotics, XF drugs have not been seen to generate bacterial resistance in industry-standard microbiology tests conducted to date and therefore have significant potential to address the global threat of AMR. XF-73 has been shown to kill bacteria very rapidly and therefore may be an effective new treatment in the reduction of bacterial infections in hospital patients, including those caused by MRSA.

MRSA is one of the most prominent superbugs and a major cause of hospital associated infection and featured in the WHO’s ‘most dangerous’ list of superbugs published in 2017. The WHO followed US and European guidelines in 2016 by recommending the screening and decolonisation of MRSA and all strains of Staphylococcus aureus in pre-surgical patients undergoing high risk surgeries in a step designed to help prevent such infections. XF-73 is targeted to address this important clinical need.

For further information, please contact:

Destiny Pharma plc
Neil Clark, CEO
Simon Sacerdoti, CFO
pressoffice@destinypharma.com
+44 (0)1273 704 440

FTI Consulting
Simon Conway / Victoria Foster Mitchell
destinypharma@fticonsulting.com
+44 (0) 20 3727 1000

Cantor Fitzgerald Europe (Nominated Adviser and Broker)
Philip Davies / Will Goode, Corporate Finance
+44 (0)20 7894 7000

About XF-73

XF-73 is a synthetic, anti-microbial drug which has demonstrated potency against all Staphylococcus aureus strains, including drug resistant strains (MRSA), tested to date. By acting via a cell-surface mechanism it affects the bacterial membrane permeability and integrity, leading to bacterial death. XF-73 has already been through five successful Phase I/IIa clinical trials showing rapid antibacterial action.

XF-73 is indicated for the prevention of post-surgical staphylococcal infections. In the US, there are approximately 40 million surgeries per annum alone where the patient is at risk of a post-surgical infection. However, within this large population there are particular groups who are at an even higher risk of infection due to the nature of their surgery or the procedures and/or their specific hospital environment in which they are treated. These higher risk surgical procedures include cardiovascular, orthopaedic and other complex surgeries. Destiny Pharma estimates that this totals approximately 14 million US surgeries per year, with this figure set to rise within the context of an ageing population.

About Destiny Pharma

Destiny Pharma is an established, clinical stage, innovative biotechnology company focused on the development of novel medicines that represent a new approach to the treatment of infectious disease. These potential new medicines are being developed to address the need for new drugs for the prevention and treatment of life-threatening infections caused by antibiotic-resistant bacteria, often referred to as “superbugs”. Tackling anti-microbial resistance has become a global imperative recognised by the WHO and the United Nations, as well as the G7 and the G20 countries. For further information, please visit https://www.destinypharma.com